Article 6 FORMULATION AND EVALUATION OF ... - jchps

Journal of Chemical and Pharmaceutical sciences
ISSN: 0974-2115
2.3.Determination of mucoadhesiveness by Wilhelmy plate method: In this method small glass plates
were coated uniformly by natural bioadhesive material solution and dried at 60 0 C. The prepared coated
plates were immersed in to U.S.P. simulated intestinal fluid (pH 6.0), or U.S.P. simulated gastric fluid (pH
1.2), for 5, 10, 15, and 20 min interval at room temperature. The force required to pull the plate out of the
solution was determined under constant experimental conditions (Gandhi and Robinson,1988).
2.4.Determination of mucoadhesiveness by Falling ball method: The synthetic polymer or natural
mucoadhesive material coated mustard seeds were passed through U.S.P. simulated intestinal fluid (pH 6.0)
at a specific distance (21 inches). The time required to pass this distance for the coated seeds were noted. All
experiments were performed at room temperature. The mustard seeds were coated with 0.75% w/v synthetic
polymer or natural mucoadhesive material solution in a small laboratory type coating pan (Chanada and
Bandopahaya, 2001).
2.5.X-Ray Diffraction study: To detect crystalline or amorphous nature of two best acting natural
mucoadhesive material x ray diffraction study has performed. The study has performed in powder
crystallographic machine model name and number (Scifert XDAL 3000) and test was performed in wave
length 1.540598nm.(Kar Asutosh,2005; Rao and Vani,1998).
2.6.In Vivo Study of natural mucoadhesion material: In vivo method is very much useful than in vitro
method because it presumably provide a more realistic picture of the expected behavior. Three formulations
containing Barium sulphate were prepared.
1. Control Barium sulphate tablets.
2. Barium sulphate tablet using natural polymer of Tamarindus indica , (seed, TS)
3. Barium sulphate tablet using natural polymer of Tamarindus indicia, (fruit, T)
Nine healthy rabbits of same age and weight were taken as subject. They were overnight fasted and on
the next day morning the tablets were administered to them followed by giving 25 ml of water. At different
time intervals of 1, 3, 5 and 8 hours the rabbits were x-ray photographed and observed for the nature and the
position of the tablets (Mishra and Mishra,1999).
2.7.Preparation of Mucoadhesive Salbutamol sulphate tablets: The tablets were prepared by wet
granulation method, using natural mucoadhesive materials extracted from tamarind seeds and tamarind fruits.
Matrix tablets of Salbutamol sulphate were prepared by conventional wet granulation method as per the
formula given in the table 6. The required quantity of medicament and matrix materials was mixed
thoroughly in a motor by following geometric dilution technique. The binder solution (mixture of alcohol
and purified water at 3:7ratio) was added and mixed thoroughly to form a dough mass. The mass was passed
through mesh number 14 to obtain wet granules. The wet granules were dried at 60ºc for 4 hours. The dried
granules were passed through mesh no.14 to break the aggregates. Talc and Magnesium Stearate were mixed
with dry granules after passing through mesh number 100 and blended in a closed polythene bag. The
granules were compressed into tablets on a rotary multi station tableting machine to a hardness of
7kg/sq. cm. using 9mm round and flat punches (Chowdary and Sundari,2003; I.P.,1996).
3. RESULTS AND DISCUSSION
The results obtained from Wilhelmy plate method and from Falling ball method were represented in
table 1 and 2 respectively. From the results obtained we can conclude that tamarind and tamarind seeds have
mucoadhesive property. X- ray diffraction study of both materials has done. The result obtained from the X-
ray diffraction study in figure 2shows tamarind seed is amorphous in nature. The in vivo test of natural
mucoadhesive materials in rabit body (figure 3) shows control Barium sulphate tablets disintegrates within 3
hours but tamarind and tamarind seed containing Barium sulphate tablets adhere up to 5 and 7 hours. The
mucoadhesive property of selected materials showed very good results in both In Vitro and In Vivo.
Dissolution study of different formulations has shown in table 3 and 4, and Tamarind Fruit T2 (1:2–
Drug:Polymer ratio) which has shown 96% release up to 12 hrs and Tamarind seed – TS2 (1:2–Drug :
Polymer ratio) has been found to show 95% release within 12hrs. An appropriate kinetic model study was
conducted by plotting the slopes for various appropriate formulations and their R 2 values (Regression
constant) were also calculated (table 5). T2 and TS2 formulations exhibited zero order release kinetics
followed by first order kinetics.
April – June 2012 63 JCPS Volume 5 Issue 2